Trial Information

The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.

OBJECTIVES:

Primary

- To determine the change in urinary prostaglandin E metabolite (PGE-M) level after
paclitaxel treatment in patients with a variety of solid tumor malignancies.

- To determine whether a change in PGE-M level correlates with paclitaxel dose.

- To determine whether the change in urinary PGE-M level correlates with patient
reporting of pain, as measured by a visual analog scale and the Brief Pain Inventory
short form (BPI-SF).

Secondary

- To determine whether leukotriene levels are affected by paclitaxel treatment.

OUTLINE: At baseline (prior to the first dose of paclitaxel), patients complete a
questionnaire about their baseline pain symptoms (including the Brief Pain Inventory short
form and the visual analog scale); cigarette smoking status and second-hand smoke exposure;
and routine use of any pain medications (including NSAIDs, selective COX-2 inhibitors, and
opioid analgesics), corticosteroids, or leukotriene antagonists (montelukast or
zafirlukast). Patients also complete questionnaires about their pain daily on days 2-7 after
paclitaxel administration.

Urine samples are collected at baseline for urinary prostaglandin E metabolite (PGE-M),
urinary leukotriene E_4 (LTE_4), and urinary cotinine levels and on day 4 for urinary PGE-M
and LTE_4 levels.